Badanie wpływu probiotyków na objawy związane z napadami u dzieci z opornymi na leki padaczką: badanie kliniczne z randomizacją
Investigating the effect of probiotics on seizure-related symptoms in children with medication-resistant epilepsy: a randomized clinical trial
W skrócie
Badacze sprawdzili, czy probiotyki mogą pomóc dzieciom z padaczką, która nie reaguje na standardowe leki przeciwpadaczkowe. U 64,5% dzieci przyjmujących probiotyki zaobserwowano zmniejszenie liczby napadów padaczkowych, w porównaniu z grupą placebo. Wyniki sugerują, że probiotyki mogą być pomocnym dodatkiem do leczenia, szczególnie u dzieci z prawidłowymi wynikami badań obrazowych mózgu, choć naukowcy podkreślają potrzebę dalszych badań, aby całkowicie potwierdzić te efekty.
Oryginalny abstract (angielski)
INTRODUCTION: Antiseizure Medications (ASMs) can be beneficial for many patients with epilepsy; however, some individuals with medication-resistant epilepsy (MRE) may not experience effective seizure control. Although effective alternative diets and non-pharmacological interventions have received much attention, there are limited studies in this regard. Therefore, this study was conducted to investigate the efficacy of probiotic intervention on children with MRE. METHODS: This prospective, triple-blind, randomized clinical trial study was conducted on 62 pediatric patients with MRE who were referred to the Children's Medical Center (the main referral center for children with epilepsy) and diagnosed by an epileptologist. Patients were randomly divided into two equally distributed groups: intervention (31 patients) with daily probiotic intake and control (31 Patients) with placebo intake. Patients were followed up at intervals of 45 days, 3 months, and 6 months regarding the number of seizures as the primary outcome, and the times and dose of anticonvulsants taken by the patient as secondary outcomes. RESULTS: In the probiotic group, 20 patients (64.5%) experienced a decrease in seizure frequency following the intervention, while 11 patients (35.5%) showed no change in their seizure frequency. This outcome was statistically significant when compared to the placebo intervention group (P = 0.007). A statistically significant relationship was found between probiotic consumption and the patient's seizure frequency after starting probiotics in patients with normal neuroimaging results (P = 0.007). Probiotic administration had a statistically significant effect only on reducing the dose of Phenobarbital. This study found that probiotic use was associated with a reduction in the number of seizures in patients with MRE. Because antiseizure medication (ASM) adjustments were not protocolized and certain confounders were not fully controlled, the causative nature of the association between probiotic use and seizure reduction cannot be ascertained.